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Showing 921–940 of 1310 results

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Vitaccino Coffee (DASH XCLUSIVE) – Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

Class IIModerate

FDAMay 11, 2021Nationwide• DASH XCLUSIVE

Metformin HCl Extended Release (Preferred) – NDMA Impurity (2021)

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Class IIModerate

FDAApr 28, 2021FL, IN• Preferred Pharmaceuticals, Inc.

Cephalexin Oral Suspension (Preferred) – impurity issue (2021)

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Class IIModerate

FDAApr 12, 2021CA• Preferred Pharmaceuticals, Inc.

Flurandrenolide Ointment (Teligent) – specification failure (2021)

Failed Impurities/Degradation Specifications:

Class IIModerate

FDAApr 9, 2021Nationwide• Teligent Pharma, Inc.

PremierZen Black 5000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

Triple SupremeZen Plus (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

PremierZen Extreme 3000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

PremierZen Extreme 3000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

Guanfacine Tablets (Apotex) - Cross Contamination (2021)

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Class IIModerate

FDAMar 31, 2021Nationwide• Apotex Corp.

Burro en Primavera (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

IMPERIAL GOLD 2000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

Imperial Platinum 2000 (QMart) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 31, 2021Nationwide• QMart

Triple SupremeZen Gold (Na Na) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 30, 2021Nationwide• Na Na Collection

PremierZen Platinum 5000 (Na Na) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 30, 2021Nationwide• Na Na Collection

Imperial Extreme 2000 Capsules (S & B Story) – Unapproved Drug Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Class IIModerate

FDAMar 25, 2021Nationwide• S & B Story LLC

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

Class IIModerate

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Class IIModerate

FDAJan 25, 2021Nationwide• Nostrum Laboratories Inc

Metformin Hydrochloride Tablets (Nostrum) – NDMA Impurity (2021)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJan 4, 2021Nationwide• Nostrum Laboratories Inc

Paroex Oral Rinse (Sunstar) – Manufacturing Contamination (2020)

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions

Class IIModerate

FDADec 28, 2020Nationwide• Sunstar Americas, Inc.

PHARMORIGINS CORE (Fusion Health) – unapproved additive (2020)

The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

Class IIModerate

FDANov 17, 2020Nationwide• Fusion Health and Vitality LLC

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